News & Analysis as of

Drug Pricing Life Sciences Health Insurance

Jones Day

Medicare's Innovation Center Charts New Direction: Part 3 – Drugs, Devices, and Data

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The Center for Medicare and Medicaid Innovation ("CMMI") is set to reshape value-based care. In the third of a three-part series highlighting this new direction, this summary is focused on CMMI's efforts regarding drugs,...more

Goodwin

Antitrust Life Sciences Quarterly Update 2025 Q1

Goodwin on

While M&A activity slowed in the first quarter of 2025, including in life sciences, there have been plenty of noteworthy developments in the antitrust space in the first 100 days of the Trump administration....more

DLA Piper

Keeping Watch on Medicare as the IRA is Implemented: Formulary Management Practices

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The Inflation Reduction Act (IRA), passed in 2022, made changes to the way drugs are covered and reimbursed in Medicare. While some of the changes taking effect this year could save the government money, beneficiaries may...more

Mintz - Antitrust Viewpoints

PBM Update: Special Edition - FTC Releases Second Interim Staff Report in PBM Inquiry

On January 14, 2025, the Federal Trade Commission (FTC) Office of Policy Planning released a second Interim Staff Report titled Specialty Generic Drugs: A Growing Profit Center for Vertically Integrated Pharmacy Benefit...more

Venable LLP

Amgen Launches Wezlana™ as the First Stelara® Interchangeable Biosimilar through Optum’s Nuvaila

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On January 1, 2025, Amgen launched the first interchangeable biosimilar of Janssen / Johnson & Johnson’s Stelara® (ustekinumab), Wezlana™ (ustekinumab-auub), as a private label product through Optum Health’s Nuvaila....more

Alston & Bird

Health Care Week in Review: Agencies issued Requirements Related to the Mental Health Parity and Addiction Equity Act final rules;...

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Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies,...more

Arnall Golden Gregory LLP

OIG Issues Favorable Advisory Opinion Involving Financial Risk Mitigation Arrangements for High-Cost Rare Disease Drug

On June 20, 2024, the U.S. Department of Health and Human Services Office of Inspector General (“OIG”) posted Advisory Opinion 24-04, a favorable opinion analyzing a refund and discount program designed to alleviate the...more

Epstein Becker & Green

Last Call for Comments on Bipartisan Discussion Draft SUSTAIN Act: Shaping 340B for the Future

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Only a few days remain for stakeholders—which includes drug manufacturers, patients, health care providers, pharmacies and others— to take advantage of a rare opportunity to influence the statutory contours of the 340B Drug...more

Akin Gump Strauss Hauer & Feld LLP

What a Difference a Year Makes: IRA’s Drug Pricing Provisions Turn One

This week marks the one-year anniversary since the enactment of the Inflation Reduction Act (IRA), which included sweeping reforms empowering the Secretary of Health and Human Services (HHS) to set prices for certain...more

Knobbe Martens

Merck Sues Federal Government Over Medicare Drug Price Negotiation Program

Knobbe Martens on

On June 6, 2023, Merck & Co. filed a lawsuit against the U.S. government in federal court over the Inflation Reduction Act (IRA)’s Medicare drug price negotiation program, which allows Medicare to directly negotiate prices...more

Goodwin

Biden Executive Order Targets Competition in Healthcare, Life Sciences to Spur Economic Activity

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On July 9, 2021, President Joe Biden issued an Executive Order (the “Order”) designed to promote competition in the American economy. The Order describes the administration’s concerns with competition in several markets,...more

Hogan Lovells

[Webinar] Looking ahead to 2021: Impacts of the election for the life sciences and health care industry - November 19th, 12:30 pm...

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Life Sciences and Health Care Horizons virtual event series - The fast pace of innovation in the life sciences and health care industry has reached an all-time high in 2020 as the industry grapples with the new reality of...more

Hogan Lovells

Trump administration proposes ambitious AKS rewrite on drug rebates, but needs answers to big questions

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In a significant step towards implementing its American Patients First blueprint for lowering prescription drug prices and patient out-of-pocket costs, the Trump administration has proposed a series of changes to the...more

Skadden, Arps, Slate, Meagher & Flom LLP

Skadden's 2019 Insights: Trump Policy Actions Could Reshape Health Care and Life Sciences Landscape

In 2018, President Donald Trump and numerous executive branch agencies announced proposals that, if implemented, will reshape the landscape for virtually every sector of the health care industry. Many of these proposals are...more

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